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Last Updated: August 13, 2022

BREO ELLIPTA Drug Patent Profile


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When do Breo Ellipta patents expire, and when can generic versions of Breo Ellipta launch?

Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are ten patents protecting this drug.

This drug has two hundred and thirty-eight patent family members in thirty-three countries.

The generic ingredient in BREO ELLIPTA is fluticasone furoate; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fluticasone furoate; vilanterol trifenatate profile page.

DrugPatentWatch® Generic Entry Outlook for Breo Ellipta

Breo Ellipta was eligible for patent challenges on May 10, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 26, 2029. This may change due to patent challenges or generic licensing.

Annual sales in 2019 were $2.6bn, indicating a strong incentive for generic entry.

Indicators of Generic Entry

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Drug patent expirations by year for BREO ELLIPTA
Drug Prices for BREO ELLIPTA

See drug prices for BREO ELLIPTA

Drug Sales Revenue Trends for BREO ELLIPTA

See drug sales revenues for BREO ELLIPTA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for BREO ELLIPTA
Generic Entry Date for BREO ELLIPTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BREO ELLIPTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Baylor Research InstitutePhase 4
Chiesi Farmaceutici S.p.A.Phase 4
Luis Puente MaestuPhase 4

See all BREO ELLIPTA clinical trials

US Patents and Regulatory Information for BREO ELLIPTA

BREO ELLIPTA is protected by sixteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BREO ELLIPTA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BREO ELLIPTA

Pharmaceutical formulations comprising 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyet- hyl}-2-(hydroxymethyl) phenol
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER

Pharmaceutical formulations comprising 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyet- hyl}-2-(hydroxymethyl) phenol
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS

Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS

Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED FOR THE ONCE-DAILY TREATMENT OF ASTHMA IN PATIENTS 18 YEARS AND OLDER

Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER

Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING BRONCHITIS AND/OR EMPHYSEMA

Inhalation devices for delivering phenethanolamine derivatives for the treatment of respiratory diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Counter for use with a medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: LONG-TERM, ONCE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS

Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER

Manifold for use in medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER

Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-001 May 10, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for BREO ELLIPTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-001 May 10, 2013 See Plans and Pricing See Plans and Pricing
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-001 May 10, 2013 See Plans and Pricing See Plans and Pricing
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BREO ELLIPTA

When does loss-of-exclusivity occur for BREO ELLIPTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Croatia

Patent: 0191257
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 00950
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 00950
Estimated Expiration: See Plans and Pricing

Patent: 78169
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 45917
Estimated Expiration: See Plans and Pricing

Japan

Patent: 09985
Estimated Expiration: See Plans and Pricing

Patent: 12518663
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 00950
Estimated Expiration: See Plans and Pricing

Poland

Patent: 00950
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 00950
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 00950
Estimated Expiration: See Plans and Pricing

Spain

Patent: 39352
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BREO ELLIPTA around the world.

Country Patent Number Title Estimated Expiration
Colombia 5611173 DISTRIBUIDOR DE MEDICAMENTO See Plans and Pricing
Israel 188930 מחלק תרופות (Medicament dispenser) See Plans and Pricing
European Patent Office 1907037 DISTRIBUTEUR DE MÉDICAMENTS (MEDICAMENT DISPENSER) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BREO ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1425001 C01425001/01 Switzerland See Plans and Pricing PRODUCT NAME: VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
1425001 1490033-6 Sweden See Plans and Pricing PRODUCT NAME: VILANTEROL, OCH SALTER OCH SOLVATER DAERAV; REG. NO/DATE: EU/1/13/886 20131113
1305329 C01305329/01 Switzerland See Plans and Pricing PRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
AstraZeneca
Baxter
Dow
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.